Expandable implant devices for filtering blood flow from atrial appendages

ABSTRACT

Implant devices for filtering blood flowing through the ostium of an atrial appendage have component structures one or more of which are expandable. Devices with component structures in their unexpanded state have a compact size suitable for intra-cutaneous delivery to an atrial appendage situs. The expandable component structures are expanded in situ to deploy the devices. A device may have sufficiently short axial length so that most or almost all of the device length may fit within the ostium region.

This application is a continuation of U.S. application Ser. No.11/185,425, filed Jul. 19, 2005, which is a continuation of U.S.application Ser. No. 09/932, 512, filed Aug. 17, 2001, which claims thebenefit of U.S. provisional application No. 60/226,461, filed Aug. 18,2000, U.S. provisional application No. 60/234,112, filed Sep. 21, 2000,and U.S. provisional application No. 60/234,113, filed Sep. 21, 2000,all of which are hereby incorporated by reference in their entiretiesherein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to implant devices that may be implanted in anatrial appendage for filtering blood flowing between the atrialappendage and an associated atrium of the heart to prevent thrombi fromescaping from the atrial appendage into the body's blood circulationsystem.

2. Description of the Related Art

There are a number of heart diseases (e.g., coronary artery disease,mitral valve disease) that have various adverse effects on a patient'sheart. An adverse effect of certain cardiac diseases, such as mitralvalve disease, is atrial (or auricular) fibrillation. Atrialfibrillation leads to depressed cardiac output. A high incidence ofthromboembolic (i.e., blood clot particulate) phenomena are associatedwith atrial fibrillation, and the left atrial appendage (LAA) isfrequently the source of the emboli (particulates).

Thrombi (i.e., blood clots) formation in the LAA may be due to stasiswithin the fibrillating and inadequately emptying LAA. Blood pooling inthe atrial appendage is conducive to the formation blood clots. Bloodclots may accumulate, build upon themselves. Small or large fragments ofthe blood clots may break off and propagate out from the atrialappendage into the atrium. The blood clot fragments can then enter thebody's blood circulation and embolize distally into the blood stream.

Serious medical problems result from the migration of blood clotfragments from the atrial appendage into the body's blood stream. Bloodfrom the left atrium and ventricle circulates to the heart muscle, thebrain, and other body organs, supplying them with necessary oxygen andother nutrients. Emboli generated by blood clots formed in the leftatrial appendage may block the arteries through which blood flows to abody organ. The blockage deprives the organ tissues of their normalblood flow and oxygen supply (ischemia), and depending on the body organinvolved leads to ischemic events such as heart attacks (heart muscleischemia) and strokes (brain tissue ischemia).

It is therefore important to find a means of preventing blood clots fromforming in the left atrial appendage. It is also important to find ameans to prevent fragments or emboli generated by any blood clots thatmay have formed in the atrial appendages, from propagating through theblood stream to the heart muscle, brain or other body organs.

U.S. Pat. No. 5,865,791 (hereinafter, “the '791 patent”) relates to thereduction of regions of blood stasis in the heart and ultimatelyreduction of thrombi formation in such regions, particularly in theatrial appendages of patients with atrial fibrillation. Morespecifically, the '791 patent relates to procedures and devices foraffixing the atrial appendages in an orientation that preventssubsequent formation of thrombi. In the '791 patent, the appendage isremoved from the atrium by pulling the appendage, placing a loop aroundthe appendage to form a sack, and then cutting it off from the rest ofthe heart.

U.S. Pat. No. 5,306,234 describes a method for surgically closing thepassage way between the atrium and the atrial appendage, oralternatively severing the atrial appendage.

Some recently proposed methods of treatment are directed towardimplanting a plug-type device in an atrial appendage to occlude the flowof blood therefrom.

A preventive treatment method for avoiding thromboembolic events (e.g.,heart attacks, strokes, and other ischemic events) involves filteringout harmful emboli from the blood flowing out of atrial appendages.Co-pending and co-owned U.S. patent application Ser. No. 09/428,008,U.S. patent application Ser. No. 09/614,091, U.S. patent applicationSer. No. 09/642,291, and U.S. patent application Ser. No. 09/697,628,all of which are hereby incorporated by reference in their entiretiesherein, describe filtering devices which may be implanted in an atrialappendage to filter the blood flow therefrom. The devices may bedelivered to the atrial appendage using common cardiac catheterizationmethods. These methods may include trans septal catheterization whichinvolves puncturing an atrial septum.

Catheters and implant devices that are large may require large puncturesin the septum. Large catheters and devices may damage body tissue duringdelivery or implantation. Damage to body tissue may cause trauma,increase recovery time, increase the risk of complications, and increasethe cost of patient care. Further the atrial appendages may vary inshape and size from patient to patient.

It would therefore be desirable to provide implant devices which aresmall and which can be delivered by small-sized catheters to the atrialappendages. It would therefore also be desirable to provide implantdevices whose size can be adjusted in situ to conform to the size of theatrial appendages.

SUMMARY OF THE INVENTION

The invention provides implant devices and methods, which may be used tofilter blood flowing between atrial appendages and atrial chambers. Thedevices are designed to prevent the release of blood clots formed in theatrial appendages into the body's blood circulation system.

All implant devices disclosed herein have adjustable sizes. A compact ornarrow size may be used for intra-cutaneous device delivery to an atrialappendage, for example, by cardiac catheterization. The devices includesize-adjusting mechanisms that allow the device size to be enlarged insitu to an expanded size conforming to the dimensions of the atrialappendage.

It an embodiment of the implant device, an expanding inner structure isdisposed inside a membrane tube. The inner structure has rigidcomponents, which when the inner structure is expanded press or pushsides of the membrane tube outward. The inner structure may beself-expanding or may, for example, be expanded by an inflatableballoon. When the inner structure is in a collapsed configuration, thedevice has a compact size suitable for delivery to and insertion in anatrial appendage, for example, by cardiac catheterization. When fullydeployed for use, a closed end of the membrane tube covers the ostium ofthe atrial appendage. Filter elements or components built into theclosed end of the membrane tube filter out harmful-size emboli from theblood flowing out of the atrial appendage. The device may be held inposition by expanding the inner structure to press sides of the membranetube against the interior walls of the atrial appendage.

Other embodiments of the implant devices may have other kinds ofinflatable or expandable structures which allow the devices to havecompact sizes for device delivery and which can later be enlarged insitu to make the device size conform to the dimensions of the atrialappendages.

The devices may have short axial lengths that are comparable to or are afraction of the length of an ostium. A short-axial length device mayhave a thin expandable or inflatable structure. The cross-sectionalshape of a thin expandable structure may, for example, resemble that ofa mushroom cap, a pill box, or a doughnut-shaped tube, etc. Thestructure may include suitable blood-permeable filter elements forfiltering harmful-size emboli from the blood flow. The filter elementsmay be located centrally or may be located off-center in the thinstructure. When deployed the thin structure covers the ostium of anatrial appendage and directs all blood flow through the ostium to passthrough the filter elements. The structure may be suitably designed toprevent unwanted flow channels (e.g., around the edges of the device)through which unfiltered blood may flow between the appendage and theatrium. The structure may have anchors attached to its outsideperiphery. These anchors may be pins, hooks, barbs, atraumatic bulb tipsor other suitable structures for engaging wall tissue. The anchorsengage the interior walls of the ostium and thereby secure the positionof the deployed device. Some devices may have axial lengths that may beslightly larger than the length of an ostium. Such devices may haveanchors disposed on posterior portions of the expandable structure forengaging interior wall tissue of the neck region of the atrial appendageleading to the ostium Other devices with expandable or inflatablestructures may have longer axial lengths that are comparable to or are asubstantial fraction of the length of an atrial appendage. Alonger-axial length device may have a first structure designed to coverthe ostium of an atrial appendage and filter blood flow therethrough.This first structure may optionally be expandable or non-expandable. Ineither case, an expandable second structure in the device may be used tohelp secure the device in its deployed position. The expandable secondstructure is generally disposed in the lumen or interior cavity of theatrial appendages. The expandable second structure may be self-expandingor may, for example, be expandable by balloon inflation. The expandablesecond structures may have components such as attached anchors forengaging the interior walls of the atrial appendages. These anchors maybe pins, hooks, barbs, atraumatic bulb tips or other suitable structuresfor engaging wall tissue. The expandable second structure mayadditionally or alternatively include inflatable anchors. Theseinflatable anchors directly engage the interior walls of the atrialappendage when inflated and provide resistance to changes in theposition of the deployed device.

Filter elements with predetermined hole size distributions for filteringharmful-sized emboli from the blood flow may be incorporated in theexpandable implant devices. The filter elements may be configured sothat their hole size distributions do not change significantly duringthe expansion of the device. In one configuration the filter elementsare embedded in elastic membranes. These membranes are designed suchthat when the devices are expanded concomitant stretching of the filterelement configurations due to the increase in device size is largelyaccommodated by the elastic membranes. The sizes of filter elementsthemselves and their predetermined hole size distributions remainsubstantially unchanged.

Further features of the invention, its nature and various advantageswill be more apparent from the accompanying drawing and the followingdetailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a cross sectional view showing an adjustable-size implantdevice at its narrow compact size suitable for delivery by cardiaccatheterization in accordance with the principles of the invention.

FIG. 1 b is a cross sectional view showing the implant device of FIG. 1a deployed in an atrial appendage. The implant device shown has membranetube having filter elements for filtering blood. The device is retainedin position by an expanded inner structure in accordance with theprinciples of the invention.

FIG. 1 c is a schematic perspective view showing an exemplary expandedinner structure in its expanded configuration in accordance with theprinciples of the invention.

FIG. 2 is a partial sectional view showing another implant devicedeployed in an atrial appendage. The implant device shown has filterelements for filtering blood and is retained in position by aself-expanding inner structure in accordance with the principles of theinvention.

FIG. 3 a is a schematic illustration of an as-delivered implant devicepositioned within an ostium. The device has a thin expandable structurewhich may be used to cover the ostium of an atrial appendage so thatblood flow between the appendage and the atrium is constrained to passthrough filter elements in the device in accordance with the principlesof the invention.

FIGS. 3 b and 3 c are cross-sectional views illustrating exemplaryshapes of the expandable structure of the implant device of FIG. 3 a.

FIG. 4 schematically illustrates the increase in size of the implantdevice of FIG. 3 a as its expandable structure is being inflated inaccordance with the principles of the invention.

FIG. 5 a is a partial cross sectional view showing an implant devicewith an expandable distal structure disposed in an atrial appendage. Theimplant device shown has a proximal structure, which may be used tocover the ostium of the atrial appendage to direct blood flow to passthrough filter elements. The device is retained in position by thedistal structure which has inflatable anchors in accordance with theprinciples of the invention.

FIG. 5 b is a side elevational view showing another implant device withexpandable structures in which a single expanding structure provides thefunctions of both the proximal and distal structures shown in FIG. 5 b,in covering the ostium and in securing the position of the device, inaccordance with the principles of the invention.

FIG. 5 c is a plan view of the implant device shown in FIG. 5 b.

FIG. 6 is a schematic illustration of a predetermined-size filterelement having holes impervious to harmful-size emboli, and an elasticmembrane attached the filter element in accordance with the principlesof the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Although atrial fibrillation may result in the pooling of blood in theleft atrial appendage and the majority of use of the invention isanticipated to be for the left atrial appendage, the invention may alsobe used for the right atrial appendage and in general for placementacross any aperture in the body in which blood is permitted to flowtherethrough or therefrom but in which blood clots are substantiallyprevented from escaping from the atrial appendage and entering into thebloodstream.

The implant devices disclosed herein have adjustable sizes. A compact ornarrow size is used for intra-cutaneous device delivery to the atrialappendages, for example, by cardiac catheterization. The devices includesize-adjusting expansion mechanisms that allow the device size to beenlarged in situ to an expanded size. Controlled expansion may bedesirable for the proper functioning of an implant device. For example,the filter elements of a device must be correctly centered or positionedacross an atrial appendage ostium for the device to properly interceptand filter blood flowing out of the atrial appendage. The expansionmechanisms allow for controlled expansion of the implanted device sizein situ to conform to the dimensions of the atrial appendage. Further,the expansion mechanisms may allow for the expansion to be at leastpartially reversed and thereby enable a physician to optimize or adjustthe deployment of the device in situ. The types of implant devicesdisclosed herein add to variety of device types disclosed in U.S. patentapplication Ser. No. 09/428,008, U.S. patent application Ser. No.09/614,091, U.S. patent application Ser. No. 09/642,291, and U.S. patentapplication Ser. No. 09/697,628, all incorporated in by referenceherein.

FIG. 1 a shows device 101 at its compact size suitable for delivery toatrial appendage 100 (FIG. 1 b) by cardiac catheterization. Device 101has a membrane tube 120 in which an expanding structure 130 is disposed.Membrane tube 120 may be made of thin flexible materials. Expandingstructure 130, in contrast, may have components which are made of morerigid material such as hard plastics or corrosion-resistant metal alloysincluding shape memory alloys. Expanding structure 130 has a collapsedconfiguration (FIG. 1 a) and a larger expanded configuration (FIGS. 1 band 1 c).

In both the collapsed and expanded configurations, structure 130 mayhave a generally cylindrical shape. Structure 130 may have a design thatallows it to expand radially without any significant concomitant changein its axial length. The design of also may allow for permanentdeformation, or partially or completely reversible deformation ofstructure 130 during its expansion. FIG. 1 c schematically illustratesportions of an exemplary inner structure 130 in its expandedconfiguration. Structure 130 shown in FIG. 1 c is similar to structuresshown and described in greater detail, for example, in U.S. applicationSer. No. 09/642,291. Structure 130 includes interconnected serpentinesegments 131. Adjacent serpentine segments 131 are interconnected by aplurality of longitudinal struts 132. End serpentine segment 131 isconnected by radial members 133 to a central hollow cylindrical ring134. Some or all of components 130-134 may, for example, be fabricatedfrom shape memory alloys.

Externally-initiated means may be used to change the configuration ofstructure 130 when it is placed in atrial appendage 100. For example,balloon 140 (e.g., placed within structure 130 through central hollowcylindrical ring 134) may be inflated to change the configuration ofstructure 130 from its collapsed configuration to its expandedconfiguration. Balloon 140 may be inflated or deflated conventionally,for example, by injecting or withdrawing suitable fluids from the bodyof balloon 140, respectively, through suitable elastic sealed openings,for example, valve structures 142. The elastic sealed openings such asvalve structures 142 prevent uncontrolled release of fluids injected into balloon 140.

FIG. 1 b shows, for example, device 101 expanded to a suitable expandedsize for permanent deployment in atrial appendage 100. Device 101 may beused to filter blood flowing out from atrial appendage 100. Device 101has a membrane tube 120 in which an expanding structure 130 is placed.Membrane tube 120 has a generally cylindrical shape and may have one orboth of its distal and proximal ends closed. FIG. 1 b shows membrane 120having both distal and proximal closed ends 124. The membrane tube 120can be made of bicompatible materials, such as, for example, ePFTE(e.g., Gortex®), polyester (e.g., Dacron®), PTFE (e.g., Teflon®),silicone, urethane, metal fibers, or other biocompatible polymers.

In one embodiment of device 101 at least portions of closed ends 124serve as filter elements 125 for filtering harmful-size emboli fromblood flow. Filter elements 125 are made of blood-permeable material.The remaining portions of membrane tube 125 (e.g., sides 126) may bemade of blood-impervious material. The materials used to fabricatemembrane tube 125 components can be any suitable bicompatible materials,such as, for example, ePFTE (e.g., Gortex®), polyester (e.g., Dacron®),PTFE (e.g., Teflon®), silicone, urethane, metal fibers, or otherbiocompatible polymers. The structure of the blood-permeable materialused to fabricate filter elements 125 is preferably a two-dimensionalscreen, a cellular matrix, a woven or non-woven mesh, or the like. Thestructure of the blood-permeable material may also be that of apermeable metal or a mesh of fine metal fibers. Further, theblood-permeable material in filter elements 125 may be coated or coveredwith an anticoagulant, such as heparin, or another compound, or treatedto provide antithrombogenic properties to the filter elements 125 toinhibit clogging of filter elements 125 by an accumulation of bloodclots.

Filter elements 125 have holes through them for blood flow. As usedherein, it will be understood that the term hole refers to an opening inthe structure of a filter element which provides a continuous openchannel or passageway from one side of the filter element to the other.The term pore refers to a small cavity in the material of a filterelement. Cavities or pores do not provide a continuous open channel orpassageway through the filter element. Partially opened surface pores,however, are an important component of surface texture which isadvantageous for cellular tissue ingrowth.

The hole sizes in the blood-permeable material included in filterelements 125 may be chosen to be sufficiently small so that harmful-sizeemboli are filtered out from the blood flow between appendage 100 andatrium 105 (shown partially in FIGS. 1 b and 1 c). Yet the hole sizesmay be chosen to be sufficiently large to provide an adequate flowconductivity for emboli-free blood to pass through device 101. Filterelements 125 may have hole sizes ranging, for example, from about 50 toabout 400 microns in diameter. The distribution the hole sizes may besuitably chosen, for example, with regard to individual circumstances,to be larger or smaller than indicated, provided such holessubstantially inhibit harmful-size emboli from passing therethrough. Theopen area of filter elements 125 is preferably at least 20% of theoverall surface area of the closed ends 124, although a range of about25-60% may be preferred.

The hole size distribution of the material used to make filter elements125, described above, allows blood to flow therethrough while blockingor inhibiting the passage of thrombus, clots, or emboli formed withinthe atrial appendage from entering the atrium of the heart and,eventually, the patient's bloodstream.

In an alternative embodiment, substantially all of membrane tube 120 maybe made of blood-permeable material suitable for filtering harmful-sizeemboli. Use of a single material (or a fewer number of different typesof materials) in membrane tube 120 may simplify its fabrication. In thiscase it may be sufficient to coat or cover closed end 124 portions withan anticoagulant to prevent clogging of blood flow between atrialappendage 100 and atrium 105. Sides 126, for example, need not be coatedwith an anticoagulant as they are likely to be sealed in any event byatrial appendage wall tissue when device 101 is deployed in an atrialappendage, as described below.

For all embodiments of device 101, for example, as described above, whenfully deployed, membrane tube 120 is held or retained in position inatrial appendage 100 so that proximal closed end 124 extends across orcovers ostium 110. After initial insertion of device 101 in atrialappendage 100, expanding structure 130 is expanded, for example, byinflating balloon 140, from its initial compact size to an expandedsize, Expanding structure 130 is expanded to a suitable size to pressmembrane tube sides 126 directly against interior walls 100 a of atrialappendage 100. The direct engagement of sides 126 with interior walltissue 100 a caused by the outward pressing by structure 130 holdsdevice 101 provides a degree of resistance to movement of device 101within atrial appendage 100 and holds device 101 in a substantiallyfixed position. However, this resistance to movement at least initiallyduring the implant procedure may be reversed to allow repositioning ofdevice 101 if necessary or desirable. The reversal may be complete orpartial corresponding to the elastic deformation characteristics ofstructure 130. The reversal may be accomplished, for example, bydeflation of balloon 140. Later, regenerative tissue growth, forexample, of endothelial or endocardial tissue, conforming to the outersurface textures of sides 126 may bind sides 126 and provide additionalsecurement of fully deployed device 101. This tissue growth binding may,for example, involve tissue ingrowth into partially-open surface poresof the material of sides 126, or, for example, tissue ingrowth intoholes in blood-permeable material in the case where sides 126 are madeof blood-permeable material having holes. This tissue growth, inconjunction with the outward pressure provided by inner structure 130,may provide additional means of reducing flow leakage about theperiphery of device 101.

In some implant procedures it may be desirable to leave balloon 140 insitus, for example, in a deflated state. In other implant procedures itmay be desirable to physically remove balloon 140 after device 101 hasbeen secured in appendage 100. As necessary or desired, balloon 140 maybe removed from the patient's body using conventional catheterizationtechniques. Balloon 140 may be withdrawn from tube 120 through suitableself-sealing openings in closed ends 124. A suitable self-sealingopening may be of the type formed by overlapping membrane flaps (e.g.,flaps 124 FIG. 1 b). Other types of conventional self-sealing openingssuch as those formed by elastic O-ring structures (not shown) also maybe used.

In further embodiments of device 101, expanding inner structure 130 maybe a self-expanding structure. Structure 130 may have suitable biasingmeans, for example, springs or other elastic components, which changethe configuration of structure 130 from its as-implanted collapsedconfiguration to its expanded configuration after device 101 has beenimplanted. Self-expanding structure 130 also may, for example, havecomponents made from shape memory alloys (e.g., Nitinol®). The shapememory alloy components may be preformed to have a shape correspondingto the expanded configuration of structure 130. The performed componentsmay be bent or compressed to form structure 130 in its collapsedconfiguration. After device implantation, heating or changingtemperature induces the bent or compressed the shape memory alloycomponents to automatically revert to their performed shapescorresponding to the expanded configuration of structure 130. FIG. 2shows, for example, device 101 expanded by self-expanding structure 200to a suitable expanded size for permanent deployment in an atrialappendage 100.

Other embodiments of the implant devices may have other kinds ofinflatable or expandable structures, which allow the devices to havecompact sizes for device delivery, and which can later be enlarged insitu to make the device sizes conform to the dimensions of the atrialappendages. An implant device of these embodiments may have one or morecomponent structures or substructures. One or more of the componentstructures or substructures in a device may be expandable or inflatable.A first type of these component structures or substructures may includeblood-permeable filter elements, and, for example, serve to filterharmful size emboli from the blood flow. A second type of the componentstructures or substructures may include anchoring elements, and, forexample, serve to retain the deployed device in position. It will beunderstood that neither component types are contemplated within theinvention as necessarily having mutually exclusive functions. Neithertype is restricted to having only filter elements or only anchoringelements. A single component structure may serve both to filter bloodflow and to hold the deployed device in position.

Different embodiments of devices having one or more of these types ofcomponent structures or substructures may have correspondingly differentaxial lengths spanning a wide range of values. At the upper end of therange, devices may have axial lengths that are comparable to or are asignificant fraction of the length of an atrial appendage. Toward thelower end of the range, devices may have axial lengths that arecomparable to or are a fraction of the length of the ostium and the neckregion of the atrial appendage leading to the ostium.

A device embodiment having a short axial length suitable for deploymentfully within an ostium is illustrated in FIGS. 3 a, 3 b, 3 c, and 4.Device 300 has a thin expandable or inflatable structure 310. FIG. 3 aschematically shows device 300 as delivered for deployment positionedwithin ostium 305. Structure 310 when expanded may have a shape, forexample, resembling a mushroom cap (FIG. 3 b), a pill box (FIG. 3 c), adoughnut-shaped tube, or any other shape suitable for engaging ostium305.

Expandable structure 310 may be fabricated from membranes or fabricsmade of bicompatible materials, such as, for example, ePFTE (e.g.,Gortex®), polyester (e.g., Dacron®), PTFE (e.g., Teflon®), silicone,urethane, metal fibers, or other biocompatible polymers. Expandablestructure 310 includes filter elements for filtering harmful-size emboli(not shown). Structure 310 may include non-expanding portions made ofblood-permeable membrane or fabric suitable for filtering harmful-sizeemboli (not shown). The non-expanding portions may, for example, in thecase where structure 310 has an expandable doughnut shape extend acrossthe central region of the doughnut shape. Structure 310 may also includeaccess openings or fixtures for attaching catheters or other deliverydevices (not shown). Anchors 330 are attached to the outer periphery ofexpandable structure 330. Anchors 330 may, for example, be attached toan outer rim toward the posterior of expandable structure 330. Anchors330 may be pins, hooks, barbs, wires with atraumatic bulb tips or othersuitable structures for engaging tissue. Device 300 is secured inposition relative to ostium 305 when anchors 330 engage surroundingostium wall tissue.

Device 300 may be suitably deployed to filter blood flowing throughostium 305 by extending expandable structure 310 across ostium 305.Expandable structure 320 may be self-expanding (e.g., like structure 130FIG. 2). Alternatively, expandable structure 310 may includeexternally-initiated mechanical means for expansion (e.g., like balloon140 FIG. 1 b). FIG. 4 schematically illustrates the increase in size ofdevice 300 as expandable structure 310 is being inflated. FIG. 4 showsdevice 300 increasing from an initial size a to an intermediate size b,and then to a size c. As device 300 size increases attached anchors 330move radially outward toward the interior walls of ostium 305. Whenstructure 310 is sufficiently expanded, anchors 330 engage surroundinginterior wall tissue and secure device 300 in position.

FIG. 5 a shows an implant device 500 having an axial length which iscomparable or a significant fraction of the length of atrial appendage100. Device 500 has two component substructures, i.e., proximalstructure 510, and distal structure 520. Proximal structure 510 may beused to cover ostium 110 of atrial appendage 100. Proximal structure 510includes blood-permeable filter elements which filter the blood flowthrough ostium 110. Proximal structure 510 may be made of a suitablefabric made from bicompatible materials, such as, for example, ePFTE(e.g., Gortex®), polyester (e.g.,

Dacron®), PTFE (e.g., Teflon®), silicone, urethane, metal fibers, orother biocompatible polymers. Proximal structure 510 may be anexpandable structure, which may, for example, be similar to expandablestructure 310 described above with reference to FIGS. 3 a, 3 b and 3 c.Alternatively, proximal structure 510 may be a structure which is notexpandable or inflatable. Non-inflatable structure 510 may, for example,be any one of the structures for covering ostium 110 described in U.S.patent application Ser. No. 09/428,008, U.S. patent application Ser. No.09/614,091, U.S. patent application Ser. No. 09/642,291, and U.S. patentapplication Ser. No. 09/697,628, all incorporated by reference herein.

In either case, structure 510 is retained in position extending acrossostium 110 by use of attached distal structure 520. Distal structure 520is inflatable and has one or more anchor sets 530 attached to an axialportion or shank 521. Each of the anchor sets 530 has a suitable numberof inflatable anchors 531 designed to engage the interior walls ofatrial appendage 100. Inflatable anchors 531 in a set 530 may beattached to axial portion 521 along a radial circumference at a suitabledistance away from proximal cover 510 (not shown). Alternatively,inflatable anchors 531 in a set 530 may be attached to axial portion 521along an axial length thereof, for example, as illustrated in FIG. 5 a.Other distributions of anchors 531 also may be used. For example,anchors 531 may be attached to axial portion 521 in a spiral pattern.Distal structure 520 including anchor sets 530 may be made of a suitablefabric made of bicompatible materials, such as, for example, ePFTE(e.g., Gortex®), polyester (e.g., Dacron®), PTFE (e.g., Teflon®),silicone, urethane, metal fibers, or other biocompatible polymers.

Device 500 is at its compact size suitable for intra-cutaneous deliverywhen distal structure 520 is deflated, and when proximal structure 510deflated or suitably folded according to whether proximal structure 510is an expanding or a non-expanding structure. In an implant procedure,device 500 in its compact size may be delivered to atrial appendage 100,for example, by cardiac catheterization. When fully deployed, device 500is positioned so that proximal structure 510 appropriately extendsacross ostium 110. Distal structure 520 is disposed to the interior ofatrial appendage 100. Distal structure 520 is inflated by suitable meansso that inflated anchors 531 engage and press against the interior wallsof atrial appendage 100. The friction between outwardly pressing anchors531 and the atrial appendage walls retains device 500 in its desiredfully deployed position. The suitable means for inflating structure 520may, for example, involve injection of fluids into structure 520 throughsuitable openings (not shown). The openings may have suitable valvedseals preventing uncontrolled release or leakage of the inflatingfluids.

In another device embodiment, a single inflatable structure may providethe functions of both the distal and proximal structures describedabove. Such a device may have a sufficiently short axial length so thatall or almost all of the device may fit within the ostium or ostiumregion of an atrial appendage Anterior portions of the device may beused cover the ostium in order to direct blood flow between the atrialappendage and the atrial chamber through filter elements. Attachedanchors may be distributed on at least part of the exterior surface areaof posterior portions of the device. The anchors may be pins, hooks,barbs, wires with atraumatic bulb tips or other suitable structures forengaging tissue. The single inflatable structure may be self-expandingor may expand in response to externally-initiated means. When the deviceis expanded the anchors attached to its posterior portions engage therear walls of the ostium and/or possibly the interior walls of the neckregion of the atrial appendage close to the ostium. The device may befabricated using suitable membranes or fabrics made of biocompatiblematerials, for example, such as those mentioned earlier. Further, thebiocompatible materials may have, for example, any of the structuresmentioned earlier (e.g., cellular matrix, wire mesh, etc.).

An exemplary implant device 550 most or almost all of which may fitwithin the ostium of an atrial appendage is illustrated in FIG. 5 b andFIG. 5 c. These two FIGS. show side elevational and top plan views ofdevice 550, respectively. Device 550 like device 300 (FIG. 3 a) has asingle component structure, i.e., expandable structure 551. Expandablestructure 551 includes anterior portion 560 and posterior portion 570.The axial length of device 550 may be comparable to or slightly largerthan the length of the ostium. Device 550 with an axial length slightlylarger than the length of the ostium, when deployed, may extend into theneck region of the atrial appendage close to the ostium.

FIG. 5 b shows device 550 at an expanded size at which it may bedeployed in the ostium. Anterior portion 560 may be fabricated from anelastic membrane and include suitable filter element 565 for filteringharmful-size emboli from the blood flow. Anterior portion 560 mayinclude suitable openings or fixtures for attaching catheters or otherdelivery devices (not shown). Anterior portion 560 is used to cover theostium to ensure that all blood flow through the ostium passes throughfilter element 565. Posterior portion 570 may, for example, be formed ofa wire mesh (as shown), a braided or woven fabric, or a short segment ofsheet material tube. Posterior portion 570 may have suitable radialdimensions conforming to the ostium dimensions. FIG. 5 c shows, forexample, a cylindrical posterior portion 570 having a substantiallyconstant diameter cross-section along its axial length. Alternatively,cylindrical posterior portion 570 may be flared with its diameterincreasing along its axial length to match changes in the ostiumdiameter, for example, as the ostium merges into the neck region of theatrial appendage (not shown).

As shown in FIG. 5 b, posterior portion 570 has barbs 575 distributedover a part of its exterior surface area close to anterior portion 560.Alternatively, barbs 575 may be distributed over all of the exteriorsurface area. When device 550 is positioned and expanded in an ostium,barbs 575 engage the surrounding ostium walls (and possibly neck regionwalls) to secure device 550 in position.

Posterior portion 570 may optionally have suitable elastic deformationproperties that cause portion 570 to recoil slightly in size from itslargest expanded size. Such suitable deformation properties may beobtained by design, for example, by choice of fabrication materials withsuitable elastic properties. The size recoil of device 550 causes barbs575 which have engaged the ostium and/or neck region walls during theexpansion of device 550 to pull back and draw the walls closer to device550. The expandable structures in other device embodiments includingthose described earlier (e.g., FIGS. 1-4, FIG. 5 a) also may havesimilar size recoil characteristics which cause attached anchors toengage and draw surrounding wall tissue closer to the devices.

The various expandable implant devices (e.g., those described above withreference to FIGS. 1-5) may have filter elements for filteringharmful-size emboli out of the blood flowing out from the atrialappendages into the atria. For effective filtering, the filter elementsshould have appropriate hole size distributions which filter outharmful-size emboli. Since the implant devices are likely to be expandedto different sizes in use, for example, to conform to the varyingdimensions of individual atrial appendages, the filter elements areconfigured so that their hole size distributions do not changesignificantly during the expansion of the device.

For example, FIG. 6 shows one configuration of filter element 600 inwhich the size distribution of holes 610 does not change significantlyduring device deployment. In the configuration shown, filter element 600is attached to elastic membrane 620. Filter element 600 and elasticmembrane 620 may, for example, be made of a suitable membrane or fabriccomposed of bicompatible materials, such as, for example, ePFTE (e.g.,Gortex®), polyester (e.g., Dacron®), PTFE (e.g., Teflon®), silicone,urethane, metal fibers, or other biocompatible polymers. Filter 600 mayhave hole sizes ranging, for example, from about 50 to about 400 micronsin diameter, suitable for filtering harmful-sized emboli. This range ofhole size distribution may be adequate to make filter element 600impervious to harmful-sized emboli, and yet provide enough permeabilityfor blood to flow through element 600. The hole size distribution may beselected, for example, by selecting the open weave density of the fabricused to make filter 600. Alternatively, for example, for filter elementsmade of solid sheet material, other techniques such as laser drillingmay be used for making small diameter holes.

Filter element 600 and elastic membrane 620 are constructed so that theformer component is substantially less elastic than the lattercomponent. This difference in elasticity may be obtained, for example,by using the same kind of material to make both components, but bymaking filter element 600 substantially thicker than elastic membrane620. Alternatively, elastic membrane 620 and filter 600 may be made oftwo different kinds of materials that have different elastic properties.The two different material components may be bonded or glued together.

Filter element 600 and elastic membrane 620 may be incorporated invarious types of implant device structures, for example, membrane tube120 FIG. 1 a, expandable structure 310 FIG. 3 a, proximal structure 510FIG. 5 a, and anterior portion 560 FIG. 5 b. When the deviceincorporating these two components is expanded, most of the concomitantstretching of the filter configuration due to the increase in devicesize is accommodated by the stretching of elastic membrane 620 leavingthe size of filter element 600 substantially unchanged from itspredetermined value.

It will be understood that the foregoing is only illustrative of theprinciples of the invention, and that various modifications can be madeby those skilled in the art without departing from the scope and spiritof the invention. It will be understood that terms like “distal” and“proximal”, anterior” and “posterior”, and other directional ororientational terms are used herein only for convenience, and that nofixed or absolute orientations are intended by the use of these terms.

1. (canceled)
 2. A device for filtering blood flowing through an ostiumof an atrial appendage, comprising: an expandable structure for coveringthe ostium; and anchors disposed on the outer periphery of theexpandable structure; wherein the expandable structure has an axiallength less than about a combined length of the ostium and a neck regionof the atrial appendage leading to the ostium; wherein the expandablestructure comprises a blood-permeable filter; wherein the anchors engagesurrounding ostium wall tissue.
 3. The device of claim 2 wherein theexpandable structure is self-expanding.
 4. The device of claim 2 whereinthe expandable structure expands in response to externally-initiatedmeans.
 5. The device of claim 4 wherein the externally-initiated meanscomprises an inflatable balloon.
 6. The device of claim 2 wherein theblood-permeable filter comprises holes that are substantially imperviousto harmful-size emboli.
 7. A method for filtering blood flowing throughan ostium of an atrial appendage, comprising: providing an expandablestructure comprising a blood-permeable filter, the expandable structurehaving an axial length less than about the length of an ostium;providing anchors attached to the expandable structure; disposing theexpandable structure within the ostium; positioning the expandablestructure to cover the ostium; and expanding the expandable structure sothat the anchors engage surrounding ostium wall tissue.
 8. The method ofclaim 7 wherein the providing an expandable structure comprisesproviding a self-expanding structure.
 9. The method of claim 7 whereinthe providing an expandable structure further comprises providingexternally-initiated means to expand the expandable structure, andwherein the expanding comprises initiating the means.
 10. The method ofclaim 9 wherein the providing externally-initiated means comprisesproviding an inflatable balloon, and wherein the initiating comprisesinflating the inflatable balloon.
 11. The method of claim 10 furthercomprising deflating and withdrawing the inflatable balloon after theanchors engage surrounding ostium wall tissue.
 12. The method of claim 7wherein the positioning the expandable structure to cover the ostiumcomprises positioning the expandable structure to direct substantiallyall blood flow through the ostium to pass through the filter.
 13. Adevice for filtering blood flowing through an ostium of an atrialappendage, comprising: a first structure comprising a blood-permeablefilter element; and a second structure attached to the first structure,the second structure comprising at least one inflatable anchor set,wherein the first structure is deployed across the ostium, and whereinthe inflatable anchor set when inflated engages interior wall tissue ofthe atrial appendage to secure the device in its deployed position. 14.The device of claim 13 wherein the second structure comprises an axialportion, wherein the at least one inflatable anchor set comprisesanchors attached to the axial portion along a radial circumferencethereof.
 15. The device of claim 13 wherein the second structurecomprises an axial portion, wherein the at least one inflatable anchorset comprises anchors attached to the axial portion along an axiallength thereof.
 16. The device of claim 13 wherein the first structurecomprises an inflatable structure.
 17. The device of claim 13 whereinthe filter element comprises holes substantially impervious toharmful-size emboli.